A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer (CYCLONE 2)

A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib in Patients With Metastatic Castration-Resistant Prostate Cancer

This study is being done to see how safe and effective abemaciclib is when given together with abiraterone acetate plus prednisone in participants with metastatic castration resistant prostate cancer. Prednisolone may be used instead of prednisone per local regulation.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: Abemaciclib; Drug: Placebo; Drug: Prednisone; Drug: Abiraterone acetate

• Study Type: Interventional
• Enrollment (Actual): 393
• Phase: Phase 2; Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Chris O'Brien Lifehouse
    • Kogarah, New South Wales, Australia, 2228
      • Southside Cancer Care Centre
    • Macquarie University, New South Wales, Australia, 2109
      • Macquarie University
    • Randwick, New South Wales, Australia, 2031
      • Prince of Wales Hospital
  • Victoria
    • Melbourne, Victoria, Australia, 3000
      • Peter MacCallum Cancer Centre
    • Melbourne, Victoria, Australia, 3065
      • St Vincent's Hospital
• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Second Affiliated hospital of Anhui Medical University
    • Wuhu, Anhui, China, 241001
      • Wannan Medical College Yijishan Hospital
  • Gansu
    • Lanzhou, Gansu, China, 730030
      • Lanzhou University Second Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-Sen University Cancer Centre
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Henan
    • Luoyang, Henan, China, 471003
      • The First Affiliated Hospital of Henan University of Science &Technology
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Wuhan Union Hospital
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Tongji Medical,Science & Technology
  • Hunan
    • Changsha, Hunan, China, 410013
      • Hunan Cancer Hospital
    • Changsha, Hunan, China, 410005
      • Hunan Provincial People's Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing
    • Nantong, Jiangsu, China, 226361
      • Nantong Tumor Hospital
    • Wuxi, Jiangsu, China, 214023
      • Wuxi People's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • The First Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China, 130021
      • Jilin Province People's Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Shandong
    • Yantai, Shandong, China, 264099
      • Yantai Yuhuangding Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital Affiliated Fudan University
  • Sichuan
    • Nanchong, Sichuan, China, 637000
      • Nanchong Central Hospital
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300060
      • Tianjin Medical University Cancer Institute and Hospital
    • Tianjin, Tianjin Municipality, China, 300211
      • The Second Hospital of Tianjin Medical University
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830000
      • Xinjiang Medical University Cancer Hospital - Urumqi
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310014
      • Zhejiang Provincial People's Hospital
    • Hangzhou, Zhejiang, China, 310003
      • The First Affiliated Hospital, Zhejiang University
    • Ningbo, Zhejiang, China, 315010
      • Ningbo First Hospital
• Denmark
  • Capital Region
    • Copenhagen, Capital Region, Denmark, 2100
      • Rigshospitalet
  • Region Sjælland
    • Næstved, Region Sjælland, Denmark, 4700
      • Næstved Sygehus
• France
  • Bordeaux, France, 33075
    • CHU de Bordeaux Hop St ANDRE
  • Auvergne-Rhône-Alpes
    • Lyon, Auvergne-Rhône-Alpes, France, 69373
      • Centre Léon Bérard
  • Languedoc-Roussillon
    • Montpellier, Languedoc-Roussillon, France, 34070
      • Centre de Cancerologie du Grand Montpellier
  • Pays de la Loire Region
    • Le Mans, Pays de la Loire Region, France, 72000
      • Clinique Victor Hugo Le Mans
  • Vendée
    • La Roche-sur-Yon, Vendée, France, 85000
      • CHD Vendee
  • Île-de-France Region
    • Créteil, Île-de-France Region, France
      • Henri Mondor Hospital
• Germany
  • Baden-Wurttemberg
    • Nürtingen, Baden-Wurttemberg, Germany, 72622
      • Studienpraxis Urologie
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen
  • Lower Saxony
    • Holzminden, Lower Saxony, Germany, 37603
      • Gesundheitszentrum Holzminden
  • North Rhine-Westphalia
    • Cologne, North Rhine-Westphalia, Germany, 50968
      • Studienzentrum Bayenthal Urologische Partnerschaft Köln
    • Mettmann, North Rhine-Westphalia, Germany, 40822
      • Urologie Neandertal - Praxis Mettmann
    • Münster, North Rhine-Westphalia, Germany, 48149
      • Universitätsklinikum Münster - Albert Schweitzer Campus
    • Wesel, North Rhine-Westphalia, Germany, 46483
      • Private Practice - Dr. Stammel & Dr. Garcia
  • Saxony
    • Leipzig, Saxony, Germany, 4105
      • Private Practice - Dr. Silvio Szymula
  • Saxony-Anhalt
    • Eisleben Lutherstadt, Saxony-Anhalt, Germany, 06295
      • Private Practice - Dr. Ralf Eckert
• Japan
  • Gifu, Japan, 501-1112
    • Gifu University Hospital
  • Kumamoto, Japan, 860-0008
    • National Hospital Organization Kumamoto Medical Center
  • Osaka, Japan, 541-8567
    • Osaka International Cancer Institute
  • Aichi-ken
    • Nagoya, Aichi-ken, Japan, 466-8650
      • Japanese Red Cross Nagoya Daini Hospital
  • Aomori
    • Hirosaki, Aomori, Japan, 036-8563
      • Hirosaki University Hospital
  • Chiba
    • Sakura, Chiba, Japan, 285-0841
      • Toho University Sakura Medical Center
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-8648
      • Hokkaido University Hospital
  • Hyōgo
    • Kobe, Hyōgo, Japan, 650-0047
      • Kobe City Medical Center General Hospital
  • Ishikawa-ken
    • Kanazawa, Ishikawa-ken, Japan, 920-8641
      • Kanazawa University Hospital
  • Kanagawa
    • Yokohama, Kanagawa, Japan, 232-0024
      • Yokohama City University Medical Center
  • Saitama
    • Ina-machi, Saitama, Japan, 362-0806
      • Saitama Prefectural Cancer Center
  • Shizuoka
    • Hamamatsu, Shizuoka, Japan, 431-3192
      • Hamamatsu University Hospital
  • Tokyo
    • Shinagawa, Tokyo, Japan, 142-8555
      • Showa University Hospital
• Netherlands
  • Utrecht, Netherlands, 3543 AZ
    • St. Antonius Ziekenhuis, locatie Utrecht
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6532 SZ
      • Canisius-Wilhelmina Ziekenhuis
  • South Holland
    • Rotterdam, South Holland, Netherlands, 3015 GD
      • Erasmus Medisch Centrum
• Romania
  • Bucharest, Romania, 31422
    • Gral Medical Diagnostic Center
  • Constanța County
    • Ovidiu, Constanța County, Romania, 905900
      • Ovidius Clinical Hospital OCH
  • Dolj
    • Craiova, Dolj, Romania, 200542
      • Centrul de Oncologie "Sfântul Nectarie"
• South Korea
  • Seoul-teukbyeolsi [Seoul]
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 3080
      • Seoul National University Hospital
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 3722
      • Severance Hospital, Yonsei University Health System
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 6351
      • Samsung Medical Center
    • Songpagu, Seoul-teukbyeolsi [Seoul], South Korea, 5505
      • Asan Medical Center
• Spain
  • Madrid, Spain, 28009
    • Hospital General Universitario Gregorio Marañón
  • Barcelona [Barcelona]
    • Barcelona, Barcelona [Barcelona], Spain, 8035
      • Hospital Universitari Vall d'Hebron
    • Hospitalet, Barcelona [Barcelona], Spain, 8907
      • Instituto Catalán de Oncología - Hospital Duran i Reynals
  • Catalunya [Cataluña]
    • Barcelona, Catalunya [Cataluña], Spain, 8036
      • Hospital Clínic de Barcelona
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28034
      • Hospital Universitario Ramon y Cajal
    • Madrid, Madrid, Comunidad de, Spain, 28041
      • Hospital Universitario 12 de Octubre
  • Málaga
    • Málaga, Málaga, Spain, 29010
      • Hospital Universitario Virgen de la Victoria
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • St. Joseph's Hospital and Medical Center
    • Phoenix, Arizona, United States, 85054
      • Mayo Clinic in Arizona - Phoenix
    • Tucson, Arizona, United States, 85719
      • The University of Arizona Cancer Center - North Campus
  • Arkansas
    • Jonesboro, Arkansas, United States, 72401
      • St. Bernards Medical Center
  • California
    • Bakersfield, California, United States, 93309
      • CBCC Global Research, Inc.
    • Fullerton, California, United States, 92835
      • Providence St. Jude Medical Center
    • La Jolla, California, United States, 92093
      • Moores Cancer Center
    • Los Angeles, California, United States, 90095
      • UCLA Hematology/Oncology - Westwood (Building 100)
    • Los Angeles, California, United States, 90024
      • TRIO-US (Translational Research in Oncology-US)
    • Monterey, California, United States, 93940
      • Pacific Cancer Care
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic_Kendle
  • Colorado
    • Lone Tree, Colorado, United States, 80124
      • Rocky Mountain Cancer Center
  • Florida
    • Hollywood, Florida, United States, 33024
      • Millennium Oncology - Hollywood
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Northside Hospital
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • M Health Fairview University of Minnesota Medical Center - East Bank
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Comprehensive Cancer Centers of Nevada
  • New York
    • Albany, New York, United States, 12206
      • New York Oncology Hematology (NYOH) - Clifton Park Cancer Center
    • Syracuse, New York, United States, 13210
      • Associated Medical Professionals - Urology
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Research Medical Center
  • Texas
    • Temple, Texas, United States, 76508
      • Baylor Scott & White Medical Center - Temple
    • The Woodlands, Texas, United States, 77380
      • US Oncology
    • The Woodlands, Texas, United States, 77380
      • Northwest Cancer Specialists PC
    • The Woodlands, Texas, United States, 77380
      • Texas Oncology - Longview Cancer Center
    • The Woodlands, Texas, United States, 77380
      • Texas Oncology Cancer Care and Research Center
    • The Woodlands, Texas, United States, 77380
      • Texas Oncology Fort Worth
    • The Woodlands, Texas, United States, 77380
      • Texas Oncology-Memorial City
    • The Woodlands, Texas, United States, 77380
      • USO-Cancer Care Center of Brevard, Inc.
    • The Woodlands, Texas, United States, 77380
      • New York Oncology Hematology (NYOH) - Clifton Park Cancer Center
    • The Woodlands, Texas, United States, 77380
      • Sansum Clinic_Kendle
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute
  • Vermont
    • Burlington, Vermont, United States, 05405
      • The University of Vermont Medical Center Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histologically confirmed adenocarcinoma of the prostate.
• Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI).

• Progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy defined as one or more of the following:

  • PSA progression
  • Radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3) for bone, with or without PSA progression
• Have adequate organ function.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

Exclusion Criteria:

• Prior therapy with cytochrome P450 (CYP)17 inhibitors.
• Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 & 6 inhibitors.
• Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostate cancer [mHSPC] are eligible). Prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior radiation or surgery to all target lesions.
• Currently enrolled in a clinical study involving an investigational product.
• Gastrointestinal disorder affecting the absorption or ability to swallow large pills.
• Clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abemaciclib; Participants received 200 milligrams (mg) abemaciclib twice daily (BID) in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.	Drug: Abemaciclib; Administered orally.; Other Names: LY2835219; Drug: Prednisone; Administered orally.; Drug: Abiraterone acetate; Administered orally.
Placebo Comparator: Placebo; Participants received placebo BID in combination with standard doses of 1000 mg abiraterone acetate once daily and 5 mg prednisone BID administered orally on a continuous dosing schedule on days 1 through 28 of a 28-day cycle until radiographic and/or symptomatic progression or until another discontinuation criterion is met.	Drug: Placebo; Administered orally.; Drug: Prednisone; Administered orally.; Drug: Abiraterone acetate; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Progression Free Survival (rPFS)	The rPFS time is measured from the date of randomization to the earliest date of investigator determined radiographic disease progression (by objective radiographic disease assessment per response evaluation criteria in solid tumors (RECIST) version 1.1 for soft tissue AND/OR radionuclide bone scan using prostate cancer working group 3 -PCWG3 criteria for bone) or death from any cause, whichever occurs first.	From Date of Randomization to Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to Prostate-Specific Antigen (PSA) Progression	The PSA progression is defined as a greater than or equal to (>=) 25 percentage (%) increase and an absolute increase of >=2 nanogram/milliliter (ng/mL) above the nadir (or baseline value if baseline is the smallest on study), which is confirmed by a second value obtained 3 or more weeks later.	From Date of Randomization to the Date of the First Observation of PSA Progression (Up to 60 Months)
Radiographic Progression Free Survival (rPFS) Determined by Blinded Independent Central Review	rPFS is defined as the time from the date of randomization to the earliest date of radiographic disease progression determined by blinded independent central review (BICR) or death from any cause, whichever occurs first.	From Date of Randomization Until Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
Objective Response Rate (ORR): Percentage of Participants With a Complete Response (CR) or Partial Response (PR)	ORR is a summary measure of best overall response (BOR) as defined by RECIST 1.1 for soft tissue per investigator assessment. BOR is derived from time point responses. All time point responses observed while on study treatment and during the short-term follow-up period (but before the initiation of post-discontinuation systemic anticancer therapy) will be included in the derivation. Each patient's BOR will be categorized as complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). A BOR of CR or PR will require confirmation, but sensitivity analyses of response-based endpoints may be performed where confirmation of a BOR of CR or PR is not required.	Baseline to Radiographic Disease Progression (Up to 60 Months)
Duration of Response (DOR)	The DoR time is defined only for responders (participants with a soft tissue BOR of CR or PR) in the measurable disease population. It is measured from the date of first evidence of soft tissue CR or PR to the earliest date of investigator determined radiographic disease progression or death from any cause, whichever is earlier.	Date of First Documented CR or PR to Date of Radiographic Disease Progression or Death from Any Cause (Up to 60 Months)
Overall Survival (OS)	The OS time is measured from the date of randomization to the date of death from any cause. If the participant was alive or lost to follow-up at the time of data analysis, OS data were censored on the last date the participant was known to be alive.	From Date of Randomization to Date of Death Due to Any Cause (Up to 60 Months)
Time to Symptomatic Progression	Time to symptomatic progression is defined as the time from randomization to any of the following (whichever occurs earlier): Symptomatic Skeletal Event (SSE), defined as symptomatic fracture, surgery or radiation to bone, or spinal cord compression.; Pain progression or worsening of disease-related symptoms requiring initiation of a new systemic anti-cancer therapy.; Development of clinically significant symptoms due to loco-regional tumor progression requiring surgical intervention or radiation therapy.	From Randomization to the Date of the First Documented Symptomatic Progression (Up to 60 Months)
Pharmacokinetics (PK): Mean Steady State Exposure of Abemaciclib	PK: Mean steady state exposure of abemaciclib.	Cycle (C) 1 Day (D) 1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN2839567	PK: Mean steady state exposure of abemaciclib metabolite LSN2839567.	C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
PK: Mean Steady State Exposure of Abemaciclib Metabolite LSN3106726	PK: Mean steady state exposure of abemaciclib metabolite LSN3106726.	C1 D1: Predose, 30 min post-dose; C1 D15, C2 D1, C2 D15, C3 D1: Post dose (28 Days Cycle)
PK: Mean Steady State Exposure of Abiraterone Acetate	PK: Mean Steady State Exposure of Abiraterone Acetate.	C1 D15, Post dose
Time to Worst Pain Progression	Time to Worst Pain Progression defined as the time from randomization to any of the following (whichever occurs earlier): For participants without opioid use at baseline (World Health Organization-Analgesic Ladder-WHO-AL ≤ 2):- Worst pain progression (an increase of 2 points from baseline on the Worst Pain Numeric Rating Scale (NRS) item on 2 consecutive evaluations), Initiation of weak or strong opioids (WHO-AL ≥ 3); For participants with weak or strong opioid use at baseline (WHO-AL ≥ 3): Worst pain progression (an increase of 2 points from baseline on the Worst Pain NRS item on 2 consecutive evaluations) without concurrent decreased opioid use (a decrease in WHO-AL of 1 or more) -Increased opioid use (an increase in WHO-AL of 1 or more).	From Randomization Through Follow-up (Up to 60 months)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

General Publications

• Smith M, Piulats J, Todenhofer T, Lee JL, Arija JA, Mazilu L, Azad A, Alonso-Gordoa T, McGovern U, Choudhury A, Horvath L, Ye D, Han W, Suzuki H, Uemura H, McKay R, Ades S, Flechon A, Pieczonka C, Fernandes MS, Hulstijn M, Lithio A, Nacerddine K, Agarwal N; CYCLONE 2 investigators. Abemaciclib plus abiraterone in patients with metastatic castration-resistant prostate cancer (CYCLONE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2025 Nov;26(11):1489-1500. doi: 10.1016/S1470-2045(25)00475-9.

Helpful Links

• A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2018
• Primary Completion (Actual): January 2, 2024
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: September 18, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: mCRPC; Metastatic Castration Resistant Prostate Cancer
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols; Androstenes; Androstanes; Abiraterone Acetate; Prednisone; abemaciclib
• Other Study ID Numbers: 16598; I3Y-MC-JPCM (Other Identifier: Eli Lilly and Company); 2016-004276-21 (EudraCT Number); 2023-506777-36-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No